DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims Status
Claims 1-6, 10, 13, 21, and 51-61 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
first rejection
Claims 1-6, 10, 13, 21, and 51-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-9, 11, 13, and 14 of U.S. Patent No. 12,090,190. Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes a spray device with desmopression identical to that of examined claim 1 save it does not describe an O/W emulsion or a permeation enhancer. Competing claim 2 specifies an O/W emulsion. Competing claim 3 specifies the same limitation as examined claim 3. Competing claim 4 gives the same blood concentration as examined claims 5 and 6. Competing claims 7 and 8 specify the amount of desmopressin to be 1.5 or 0.75 µg respectively, similar to examined claims 51-61. Competing claim 9 describes a method of treating nocturia in an adult patient, using the device described identically as competing claim 1. Competing claim 11 specifies antidiuresis for less than about 6 hrs, overlapping with examined claim 21. Competing claims 13 and 14 describe a permeation enhancer, specifically, cyclopentadecanolide.
second rejection
Claims 1-6, 10, 13, 21, and 51-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 11, 12, 14, and 15 of U.S. Patent No. 11,419914 in view of Gyurik et al (US 7,244,703)
Competing claim 1 describes a method of inducing an antidiuretic effect (a treatment for a small genus of disorders, including nocturia), comprising administering desmopressin using the same dispenser used in the method of examined claim 1. Competing claim 2 specifies the Cmax identically with examined claims 6 and 10. Competing claim 5 specifies an effect of less than about 6 hrs, overlapping with that of examined claim 21. Competing claims 11 and 12 specify a dosage of 1.5 or 0.75 µg of the drug, similar to that of examined claims 51-61. Competing claims 14 and 15 specify a permeation enhancer, specifically, cyclopentadecanolide. While the competing claims do not specify the annular shape of competing claim 1 at 3 cm, given the size of the nose, the limitation of the shape of the spray implies that the shape holds at this distance.
The difference between the competing claims and the examined claims is that the competing claims do not discuss O/W emulsions.
Gyurik et al discuss formulations for nasal delivery of peptides (column 1, line 14), similar to the competing claims. However, without a means to enhance diffusion through the mucous membranes yields poor bioavailability (column 2, lines 15-20). A permeation enhancer, such as the preferred enhancer cyclopentadecanolide, same as the competing claims, can be used to overcome this issue (column 3, line 64-67). A preferred embodiment is an O/W emulsion, with the enhancer in the oil droplets and the pharmaceutical in the continuous aqueous phase (column 5, line 9-15). This reference discusses O/W emulsions in formulations and applications similar to those of the competing claims.
Therefore, it would be obvious to formulate the composition used in the method of the competing claims as an O/W emulsion as a substation of one element (the unspecified formulation of the competing claims) for another (the O/W emulsion of Gyurik et al) yielding expected results (improved uptake). As Gyurik et al discusses this as a generic way to improve uptake for this administration route, an artisan in this field would attempt this formulation with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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